Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening

Conditions

• Breast Cancer, Liquid Biopsy, Early Detection

Eligibility Criteria

Sex

FEMALE

Age

30 Years - 75 Years

Healthy Volunteers

Accepted

Study Details

Breast cancer is the most common cancer that spreads beyond the initial layer of tissue it developed in, and grows into surrounding healthy tissue in women worldwide. It is associated with significant illness and death. Identifying the disease in the early stage is important to achieving positive outcomes in response to diagnosis and treatment. The Syantra blood test has been developed over the past 10 years. This test involves examining blood samples to identify and analyze specific information. This information is run through a software program that then potentially identifies the presence of breast cancer in the blood sample. This test has the potential to increase early stage detection of breast cancer. The main goal of this study is to figure out how well the Syantra blood test identifies the presence of breast cancer in women 30-75 years of age. The study will also look at whether things like ethnicity, geography and certain individual characteristics (including breast density and elevated risk of breast cancer development) have an effect on how well the test works. This study will recruit women who are attending a visit at the site who are aged 30-75 who are undergoing testing for the presence of breast cancer as part of their regular screening or planned follow up imaging and/or biopsy. Participants who provide consent and meet eligibility criteria will complete a baseline questionnaire and have their blood drawn before any scheduled procedures. Relevant information will be collected from their medical record at the time of joining the study and will be reviewed and updated within 60 days and then again at 12 months following the baseline blood draw. Participants will not have to do anything after the initial visit where they may sign consent, complete the intake questionnaire and have their blood drawn.

Key Dates

Start date

Jan 7, 2026

Status verified

Mar 2026

Primary completion

Jun 14, 2027

Completion

Jun 14, 2027

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: Elevated risk population - Asymptomatic
  Women at elevated risk undergoing screening for breast cancer who are currently undergoing asymptomatic screening. Presentation of factor(s) indicating elevated risk for breast cancer development including: germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or 1.67% or greater 5-year breast cancer risk using the BCSC model
• Arm: Elevated risk population -Recall
  Women at elevated risk undergoing screening for breast cancer who are currently undergoing recall screening. Women who have undergone previous MRI and/or screening mammogram or ultrasound indicating follow-up imaging or biopsy recommended and who may have presentation of factor(s) indicating elevated risk for breast cancer development. Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or BOADICEA v6.0 or 1.67% or greater 5-year breast cancer risk using the BCSC model.
• Arm: Recall (Secondary care) Symptomatic population
  Women recommended for follow-up due to physical symptoms. This includes recommendation for diagnostic imaging and/or biopsy due to physical symptoms.
• Arm: Asymptomatic average, low or unknown risk population
  Women undergoing routine screening for breast cancer. Women in the Screening population would have no physical symptoms and be consented near the time of a screening imaging session (within 3 months). Recruitment may also occur after a screening imaging session with a recommendation for follow-up imaging, or after diagnostic imaging with a recommendation for a biopsy as part of the recall population.

Primary Outcome Measure

Sensitivity [ Time Frame: 3 years ]

Locations (2)

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